Sterilisation ManagerOur client, a global healthcare organisation are currently recruiting for a Sterilisation Manager for their medical device manufacturing and R&D site. As Sterilisation Manager you will be responsible for leading sterilisation activities in compliance with applicable quality systems, regulatory requirements, and internal policies. You will provide technical leadership and subject matter expertise across sterilisation validation, qualification and ongoing compliance.ResponsibilitiesLead a team responsible for sterilisation qualification for new products and changes to existing productsManage radiation sterilisation validation, including dose setting and routine dose auditsOversee ethylene oxide (EO) sterilisation validation, including new product qualification, annual revalidation, EO residual studies and D-value studiesAct as Sterilisation Subject Matter Expert, supporting Product Development, Manufacturing and Operations teamsSupport supplier quality audits of external sterilisation vendors and third-party manufacturersLead investigations into dose audit failuresLead investigations into EO biological indicator sterility positivesEnsure all activities are executed in line with regulatory and quality system requirementsRequirementsBachelor's degree in a relevant scientific or engineering disciplineMinimum 9+ years' relevant experience, or an equivalent combination of education and experienceAdvanced degree desirableStrong technical knowledge of radiation and/or ethylene oxide sterilisation (other modalities advantageous)Recognised Subject Matter Expert within sterilisation or microbiologyProven experience leading technical teams in a regulated, quality-driven environmentStrong understanding of sterilisation validation, revalidation and troubleshootingAbility to analyse complex technical issues and exercise sound judgement within established quality and regulatory frameworksExperience working cross-functionally with R&D, Quality, Manufacturing and Supplier Quality teams